Description of Event or Problem · 0
EVENT DESCRIPTION: AFTER COMPLETING A LAPAROSCOPIC OVARIAN SURGERY FOR OVARIAN CYSTS AND SUBMUCOSAL FIBROIDS, A HYSTEROSCOPIC TCR (HYSTEROSCOPIC SURGERY) WAS SCHEDULED, AND ONE DILAPAN-S WAS INSERTED. AFTER 2 HOURS OF CERVICAL DILATION, THE DOCTOR TRIED TO REMOVE THE DILAPAN-S USING LOCKING HEMOSTATIC FORCEPS UNDER THE ECHO GUIDE TO GRASP THE HANDLE AND PULL IT OUT. AFTER ABOUT TWO ATTEMPTS, THE DILATOR GOT TORN. THE CERVIX WAS STRAIGHT WITH NO FLEXION. ADDITIONAL CERVICAL DILATION WAS ATTEMPTED BY INSERTING HEGAR FROM #1 UP TO #14 IN SEQUENCE TO REMOVE THE TORN FRAGMENT, BUT ALTHOUGH DILATION WAS POSSIBLE UP TO 2 OR 3 CM, THE HEGAR COULD NOT BE INSERTED ANY FURTHER. FOR ABOUT AN HOUR, THE DOCTOR TRIED TO REMOVE THE DILAPAN-S FRAGMENT, BUT WITHOUT SUCCESS. HE HAD TO PUSH THE FRAGMENT INTO THE UTERINE CAVITY DUE TO EXCESSIVE BLEEDING. SINCE THERE WERE ALSO FIBROIDS IN THE UTERINE CAVITY, IT WAS DIFFICULT TO CRUSH THEM WITH ALLIS FORCEPS, WHICH LED TO LAPAROTOMY. THERE IS A CAUSAL RELATIONSHIP BETWEEN USE OF DILAPAN-S AND LAPAROTOMY SURGERY THAT WAS PERFORMED TO REMOVE THE RETAINED FRAGMENT OF THE DILATOR. CONCLUSION OF INVESTIGATION: INVESTIGATION OF THE PROVIDED DESCRIPTION OF THE EVENT TOGETHER WITH A PHOTO INDICATES TWO MOST PROBABLE ROOT CAUSES (A, B) THAT COULD RESULT IN DIFFICULTIES DURING REMOVAL. BOTH CAUSES IN COMBINATION TO THE PRE CONDITIONS OF THE PATIENT (SUBMUCOSAL FIBROIDS) COULD LEAD TO SUCH EVENT. A. THE DILATOR WAS NOT FULLY EXPOSED TO DESIRED CONDITIONS FOR SWELLING. THE PROXIMAL PART OF THE DILATOR WAS PROBABLY NOT INSERTED INTO SUFFICIENTLY MOIST CONDITIONS AS THE DISTAL PART OF THE DILATOR, THAT LED TO UNEVEN ABSORPTION OF THE MOISTURE AND UNEVEN INCREASING ITS DIAMETER DURING 2 HOURS IN SITU. THIS CIRCUMSTANCE COULD BE CAUSED BY INCORRECT/INSUFFICIENT INSERTION OF THE DILATOR OR SPONTANEOUS EXPULSION DUE TO FIBROIDS. B. THE FIBROIDS CAUSED "DUMBELING" EFFECT WITH A TIGHT OBSTACLE IN THE CERVICAL CANAL THAT LED TO STRANGULATION OF THE DILATOR AND UNEVEN SWELLING. IN BOTH CASES THIS KIND OF ENTRAPMENT CONTRIBUTED TO THE FRAGMENTATION OF THE DILATOR DURING REMOVAL ATTEMPTS, CAUSING THE FRAGMENTATION AND THE FRAGMENT GETTING STUCK. DEVICE ENTRAPMENT, FRAGMENTATION AND "DUMBELING" ARE KNOWN COMPLICATIONS THAT MAY OCCUR DURING A DILATION PROCEDURE. THEIR LIST IS EMPHASIZED IN THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE, TOGETHER WITH THE RECOMMENDED STEPS HOW TO PROCEED IN CASE OF THEIR OCCURRENCE. BASED ON THE PROVIDED DESCRIPTION OF THE EVENT, THE PHYSICIAN WAS AWARE OF THE INSTRUCTIONS IN THE INSTRUCTIONS FOR USE INCLUDING THE ASSOCIATED COMPLICATIONS AND FOLLOWED THE RECOMMENDED PROCEDURE TO THE EXTENT CLINICALLY REASONABLE.